Principal Specialist Regulatory Affairs

Principal RA Specialist

Scope of the role

Global

Position Summary

Possesses and applies comprehensive strategic and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.

Key areas of responsibility

• Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy                                                                                                                
• Participates in advocacy activities of a more advanced strategic nature  
• Develops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies
• Provides guidance to integrate regulatory considerations into global product entry and exit strategy
• Identifies regulatory pathways for initial product designs and provides input to internal stakeholders
• Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes
• Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles
• Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations
• Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy)
• Negotiates with regulatory authorities on complex issues throughout the product lifecycle
• Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution
• Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures
• Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
• Provides strategic input and technical guidance on global regulatory requirements to product development terms
• Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions
• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions
• Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans
• Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases
• Provides knowledge and critical analysis of preapproval inspections, GCP inspections and clinical investigator relationships
• Provides regulatory guidance on strategy for proposed product claims/labeling
• Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims
• Manages electronic (eCTD) and paper registration development
• Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions
• Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process
• Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committees
  
  

Education / Work Experience

• BS in Engineering, Science, or related Advanced degree desired or MS in Regulatory Science
• Typically, a minimum of 9 relevant RA years experience
• RAC(s) desired
  
  

Knowledge / competencies

• Articulates the organizations strategic vision in a manner that enables others to execute plans, tactics, and actions
• Continually identifies and informs appropriate individuals on emerging trends, opportunities, and threats
• Leverages a well-grounded knowledge of applicable laws, regulations and policies to develop and execute plans and programs
• Ensures strategies, analyses, and plans consider anticipated long-range requirements and are not just based on the current situation
• Makes informed decisions based on business frameworks and tools and give consideration to risks tradeoffs, timing, and available resources
• Proactively manages and monitors progress against desired outcomes including working with others to establish and adjust contingency plans, revising and adapting processes, communicating success and learning from mistakes
• Demonstrates the ability to build agreement and acceptance through an ability to present a compelling case for ideas, negotiate persuasively, and address disagreements constructively
• Continuously develops staff by making accurate assessments of individuals capabilities and performance, and providing feedback, coaching, guidance, and mentoring
• Demonstrates sensitivity and understanding of cultural considerations when dealing with others
• Embraces scrutiny and accepts feedback as opportunity to learn and improve
• Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities
  
  

 

Posted Date: 03/31/2026 This role will be posted for a minimum of 3 days.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

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